Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT03121599 |
Date of registration:
|
17/04/2017 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms
|
Scientific title:
|
A Study of 18F-FLT Positron Emission Tomography (PET)/Computed Tomography Imaging in Pediatrics With Myeloproliferative Neoplasms |
Date of first enrolment:
|
June 11, 2017 |
Target sample size:
|
3 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT03121599 |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Qatar
| | | | | | | |
Contacts
|
Name:
|
Mohamed Yassin |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hamad Medical Corporation |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Cases fulfilling WHO (World Health Organization) 2016 diagnostic criteria for MPN
including: Chronic myeloid leukemia, BCR-ABL1-positive (BCR-ABL = fusion gene from BCR
(breakpoint cluster region gene/BCR gene product), Chronic neutrophilic leukemia
(CNL), Polycythemia vera, Primary myelofibrosis prefibrotic/early stage, Primary
myelofibrosis overt fibrotic stage, Essential thrombocythemia, Chronic eosinophilic
leukemia, not otherwise specified (NOS) and Myeloproliferative neoplasm,
unclassifiable.
- Age between 14 and 18 years old
- Patient accepts to sign inform consent
- ECOG (Eastern Cooperative Oncology Group) performance less than or equal 2
Exclusion Criteria:
- Patient not fulfilling the inclusion criteria.
- Vulnerable groups: pregnant, minors, prisoners will not be included.
Age minimum:
14 Years
Age maximum:
18 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Polycythemia Vera
|
Essential Thrombocythemia
|
Primary Myelofibrosis, Prefibrotic Stage
|
Primary Myelofibrosis, Fibrotic Stage
|
Intervention(s)
|
Device: Diagnostic (18F-FLT PET/CT)
|
Primary Outcome(s)
|
Evaluate the uptake of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) in children with MPNs
[Time Frame: 12 Months]
|
Secondary Outcome(s)
|
Number of patients who have similar diagnosis and pattern between FLT and Bone Marrow
[Time Frame: 12 months]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|